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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MERIDIAN; 8" APM SYSTEM

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EEZCARE MEDICAL CORP. MERIDIAN; 8" APM SYSTEM Back to Search Results
Model Number 4800
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Head Injury (1879)
Event Type  Injury  
Event Description
The end-user fell out of bed sustaining a head injury and had to be transported by ambulance.The end-user received stitches.Bed rails were not in use when the patient fell.No visible defect with the air mattress.
 
Event Description
Customer returned a different serial number and different item of reported device.Serial number (b)(4) and item 4800 was returned for inspection.Inspector did not realize it was a different item/different serial number at time of report.Customer initially reported serial number (b)(4) and item mer-4500 in email, sent in a picture of serial number (b)(4), and returned serial number (b)(4) and item 4800.
 
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Brand Name
MERIDIAN
Type of Device
8" APM SYSTEM
Manufacturer (Section D)
EEZCARE MEDICAL CORP.
no. 3-1, minquan street
tu-cheng district
new taipei city taipe, 23679
TW  23679
MDR Report Key7530357
MDR Text Key108798096
Report Number3012316249-2018-00028
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number4800
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA05/21/2018
Distributor Facility Aware Date05/01/2018
Device Age9 MO
Date Report to Manufacturer05/21/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age80 YR
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